Propecia (Finasteride) - Summary

PROPECIA SUMMARY

PROPECIA (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5(alpha)-reductase, an intracellular enzyme that converts the androgen testosterone into 5(alpha)-dihydrotestosterone (DHT).

PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area (see CLINICAL PHARMACOLOGY, Clinical Studies).

Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated in women (see CLINICAL PHARMACOLOGY, Clinical Studies and CONTRAINDICATIONS).

PROPECIA is not indicated in children (see PRECAUTIONS, Pediatric Use).

See all Propecia indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Propecia (Finasteride)

Change in sexual function in men with lower urinary tract symptoms/benign prostatic hyperplasia associated with long-term treatment with doxazosin, finasteride and combined therapy. [2014]
Inventory during 4 years... CONCLUSIONS: This study significantly extends understanding of the effects of

Long-term effects of doxazosin, finasteride, and combination therapy on quality of life in men with benign prostatic hyperplasia. [2013]
International Prostate Symptom Score [IPSS]-QoL) over 4 years... CONCLUSIONS: QoL of men treated with doxazosin, finasteride, and

Long-term effects of doxazosin, finasteride and combination therapy on quality of life in men with benign prostatic hyperplasia. [2013]
International Prostate Symptom Score-QoL) during 4 years... CONCLUSIONS: The quality of life of men treated with doxazosin, finasteride, and

A randomized phase IIb presurgical study of finasteride vs. low-dose flutamide vs. placebo in men with prostate cancer. Efficacy monitored by karyometry. [2013]
preventive agents in patients with CaP... CONCLUSION: This exploratory study establishes that karyometric monitoring can

Comparison of dutasteride and finasteride for treating benign prostatic hyperplasia: the Enlarged Prostate International Comparator Study (EPICS). [2011.08]
OBJECTIVE: * To assess the efficacy and safety of dutasteride compared with finasteride in treating men with symptomatic benign prostatic hyperplasia (BPH) for 12 months... CONCLUSION: * Dutasteride and finasteride, when administered for 12 months, were similarly effective in reducing prostate volume and improving Q(max) and urinary symptoms associated with BPH in men with an enlarged prostate. (c) 2011 THE AUTHORS. BJU INTERNATIONAL (c) 2011 BJU INTERNATIONAL.

more studies >>

Clinical Trials Related to Propecia (Finasteride)

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition [Completed]
The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®) 1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.

Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition [Completed]
The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®) 1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer [Recruiting]
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.

Finasteride for Chronic Central Serous Chorioretinopathy [Terminated]
Background:

- Central serous chorioretinopathy (CSC) is a disease that causes fluid to collect under

the retina. It affects the macula, which is in the center of the retina and is needed for sharp, clear vision. In many cases, CSC resolves on its own and does not need treatment. However, in some cases it does not go away or comes back after treatment. This is known as chronic CSC.

- Chronic CSC may be caused by hormones called androgens. Finasteride is a drug that can

alter the effects certain of androgens. Researchers want to compare finasteride with a placebo to see if it is a safe and effective treatment for chronic CSC. Objectives:

- To see if finasteride is a safe and effective treatment for chronic CSC.

Eligibility:

- Individuals at least 18 years of age who have chronic CSC in one or both eyes.

Design:

- Participants will be screened with a physical exam and medical history. A full eye exam

will be performed. Blood and urine samples will also be collected.

- Some participants may have photodynamic therapy (PDT), the standard treatment for CSC.

PDT helps to reduce the amount of fluid in the eye. Participants will need to wait for 3 months after PDT before starting the finasteride study.

- Participants will be separated into two groups. One group will take finasteride 5 mg

(formulated into capsules); the other group will take a placebo capsule. All participants will take the capsules for 3 months.

- After 3 months on the assigned capsule (finasteride or placebo), all participants will

have the opportunity to take finasteride for at least another 4 years and 9 months. This phase of the study is optional.

- Participants will have regular study visits. At each visit, they will have physical

exams and eye exams. They will also provide blood and urine samples.

- During the first 3 months, participants will have 2 study visits. After 3 months, if

the participant continues in the optional (or as needed) phase of the protocol, visits will occur at Month 6, Month 12 and every 12 months thereafter. However, additional visits may be needed.

A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy [Completed]
The purpose of this study is to assess whether six months of daily finasteride (PROSCAR), following an initial negative prostate biopsy, will improve the detection of prostate cancer on repeat biopsy. 144 subjects with an initial negative prostate biopsy will be randomized to receive either finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy following drug intervention. PSA (prostate specific antigen) measurements, testosterone levels, and quality of life questionnaires will also be assessed during the study. The two groups will then be compared.

more trials >>

Reports of Suspected Propecia (Finasteride) Side Effects

Erectile Dysfunction (310),  Anxiety (260),  Sexual Dysfunction (247),  Depression (231),  Libido Decreased (228),  Cognitive Disorder (167),  Ejaculation Failure (124),  Ejaculation Disorder (123),  Loss of Libido (81),  Emotional Distress (71), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Propecia review by 49 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hair loss
Dosage & duration:		standard (dosage frequency: once a day) for the period of 3 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Hair regrowth in crown area
Side effects:		there were none
Comments:		One pill taken orally daily

Propecia review by 46 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Hairloss
Dosage & duration:		.8mg taken 4 days on, 1 day off for the period of 8-9 years
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		With using generic finasteride there's no doubt that further hairloss has been prevented in my case. Before beginning on this, my hairloss was rapidly escalating, both at the front and back, and this ceased and slightly reversed once started, and hasn't progressed since.
Side effects:		Definitely loss of libido, tiredness, some fogginess of thought, loss of muscle tone, occasional testicular pain, lowered blood pressure, increased floaters in vision, some gynecomastia when cycling down (minimised by taking Zinc on those days, but I would say not to discontinue this medication suddenly if taking a break or quitting).
Comments:		Mostly generic Proscar - 5mg tablets cut into six equal pieces - 4 days on and one day off in a continuing cycle.

Propecia review by 21 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Hair Loss
Dosage & duration:		1 pill a day taken once a day for the period of 15 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		after taking propecia for over a year, starting when i was 20 years of age my hair continued to thin, and i noticed no significant benefits
Side effects:		Low sex drive, before i started taking this drug i was 19 years of age and full of "enthousiasm". Now engaged and 21 years old, my sex drive is very low, my wife and I are very unsatisfied. I am also very tired even during peak hours throughout the day, and its hard to concentrate on mundain tasks
Comments:		one pill once daily